Model: NG4BLKL-100
DI: 00850015109768
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
OWELL Black Nitrile Gloves, LARGE (100 Count)
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
5394e7f0-9ce3-4ad3-aeb5-20d1c5ee2c77
Distribution Status:
In Commercial Distribution
DUNS Number:
123151704
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850015109768
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 56286
Name: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Definition:
A device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.
FDA Product Codes
LZA
Polymer Patient Examination Glove